Statistical monitoring of clinical trials with multivariate response and/or multiple arms: A flexible approach

Lihui Zhao, X. Joan Hu, Stephen W. Lagakos

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

Randomized clinical trials with a multivariate response and/or multiple treatment arms are increasingly common, in part because of their efficiency and a greater concern about balancing risks with benefits. In some trials, the specific types and magnitudes of treatment group differences that would warrant early termination cannot easily be specified prior to the onset of the trial and/or could change as the trial progresses. This underscores the need for more flexible monitoring methods than traditional approaches. This paper extends the repeated confidence bands approach for interim monitoring to more general settings where there can be a multivariate response and/or multiple treatment arms and where the metrics for comparing treatment groups can change during the conduct of the trial. We illustrate the approach using the results of a recent AIDS clinical trial and examine its efficiency and robustness via simulation.

Original languageEnglish (US)
Pages (from-to)310-323
Number of pages14
JournalBiostatistics
Volume10
Issue number2
DOIs
StatePublished - Apr 2009

Keywords

  • Group sequential analysis
  • Interim review
  • Multiple comparisons
  • Multiple end points
  • Nonparametric inference
  • Repeated confidence bands

ASJC Scopus subject areas

  • Statistics and Probability
  • Statistics, Probability and Uncertainty

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